Computer-assisted multifactorial method development for the streamlined separation and analysis of multicomponent...

Area of Science:

• Analytical Chemistry
• Biopharmaceutical Analysis
• Chromatographic Science

Background:

• The biopharmaceutical industry faces challenges with complex drug modalities requiring advanced analytical technologies.
• Manual and unsystematic method development hinders efficient assay deployment for emerging therapeutics.

Purpose of the Study:

• To review computer-assisted multifactorial chromatographic method development strategies for biopharmaceutical characterization and purification.
• To highlight the role of digitalization and automation in streamlining analytical workflows.

Main Methods:

• Discussion of various chromatographic techniques: reversed-phase liquid chromatography (RPLC), hydrophilic interaction liquid chromatography (HILIC), ion exchange chromatography (IEX), hydrophobic interaction chromatography (HIC), and supercritical fluid chromatography (SFC).
• Analysis of key parameters for retention mechanism modeling and separation landscape mapping.
• Outline of computer-assisted optimization approaches including linear, nonlinear, and multifactorial modeling.

Main Results:

• Demonstration of computer-assisted strategies for optimizing chromatographic selectivity and resolution.
• Illustration of substantial productivity improvements and cost savings.
• Acceleration of method development, deployment, and transfer processes for therapeutic analysis.

Conclusions:

• Computer-assisted chromatographic method development is crucial for efficient biopharmaceutical analysis.
• Digitalization and automation significantly improve productivity and reduce costs in industrial settings.
• These strategies enable faster characterization and purification of complex drug modalities.